# US 11,309,065 B2 · Management and tracking solution for specific patient consent attributes and permissions

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- Number: US 11,309,065 B2
- Document ID: US11309065B2
- Status: Granted
- Kind: B2
- Application number: 16/280,750
- Filed: 2019-02-20
- Published: 2020-08-20
- Granted: 2022-04-19
- Earliest claimed: 2019-02-20
- Assignees: IQVIA Inc.
- Applicants: IQVIA Inc.
- Inventors: Peter Hassett
- Web page: https://patentgrep.com/patent/US11309065B2

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
- G06F 40/174: Form filling; Merging
- G06F 40/197: Version control (for software G06F8/71)
- G06Q 10/10: Office automation; Time management
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G06F 3/0482: Interaction with lists of selectable items, e.g. menus
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR

## Abstract

A method of managing consent using a computing device, the consent is given by a subject to one or more events in one or more studies, wherein the consent and the plurality of activities are changeable, the method including: authoring one or more first data forms describing the one or more events and one or more selections responsive to the one or more events; authoring, for each of the plurality of subjects, one or more second data forms including description of a plurality of preferences; forming, for a first of the plurality of subjects, an Informed Consent Forms document by combining the one or more first data forms of a first of the one or more studies and one or more second data forms for the first subject; and generating a manifest indicating the one or more events in the first study to which the first subject has granted consent.

## Claims

### Claim 1

A method of managing consent given by subjects to events in a study, wherein the events are described by attributes including values, and wherein the values are changeable, the method comprising:
authoring a first data form describing the attributes and the respective values, and a second data form to permit the subjects to consent to the values of the attributes of the first data form;
combining the first data form and second data form into an informed consent form (ICF) for each of the subjects;
obtaining consent of each of the subjects to the respective ICF;
generating a manifest for each of the subjects, wherein each manifest includes the attributes and the values of the study to which the respective subject has consented, wherein each manifest further includes a version number of the attributes and the values, and wherein the version number changes when the values of the attributes change;
repeating the combining, the obtaining, and the generating when an attribute and/or a value of the first data form is modified to provide a re-generated manifest for each of the subjects who consents to the modified attribute and/or value; and
generating a report based on the re-generated manifests, wherein the report includes a listing of the subjects, values consented to, and a consent status for each subject based on the version number of uniqueness of the attributes and the values.

### Claim 2 (depends on 1)

The method of claim 1, wherein the study comprises clinical research and the events comprise taking and using of biological samples and specimens.

### Claim 3 (depends on 1)

The method of claim 1, further comprising identifying, from the ICFs, the respective subjects who consented to the events.

### Claim 4 (depends on 1)

The method of claim 1, wherein the repeating comprises:
re-authoring the first data form to modify the attributes and/or the respective values;
combining the re-authored first data form and the second data form into an additional ICF for each of the subjects;
obtaining consent of one or more of the subjects to the respective additional ICF; and
re-generating the manifest for each of the subjects who consents to the additional ICF, wherein each re-generated manifest includes the attributes and the values of the study to which the subject has consented and the version number of the attributes and the values.

### Claim 5 (depends on 4)

The method of claim 4, further comprising assigning version numbers to the ICFs and the additional ICFs.

### Claim 6 (depends on 5)

The method of claim 5, further comprising de-identifying patient identifying information from the manifests.

### Claim 7 (depends on 4)

The method of claim 4, further comprising digitally storing the ICFs and the additional ICFs in databases accessible to computer devices via a network.

### Claim 8 (depends on 7)

The method of claim 7, wherein the descriptions of the events are stored as metadata and the selections are stored as attributes, and wherein the attributes comprise values selected from one of static and dynamic.

### Claim 9 (depends on 8)

The method of claim 8, wherein the obtaining consent of each of the subjects to the respective ICF and the obtaining consent of one or more of the subjects to the respective additional ICF each comprises obtaining an electronic signature of each of the respective subject, and wherein the attributes are conferred to the subjects upon receipt of the respective electronic signatures.

### Claim 10 (depends on 1)

The method of claim 1, further comprising de-identifying patient identifying information in the report.

### Claim 11 (depends on 5)

The method of claim 5, further comprising:
generating a unique identifier associated with the unique version numbers of the ICFs and the additional ICFs; and
labeling the events using the version numbers corresponding to the respective subjects.

### Claim 12

A non-transitory computer readable medium encoded with a computer program that comprises instructions to cause a processor to manage consent given by subjects to events in a study, wherein the events are described by attributes including values, and wherein the values are changeable, including to:
author a first data form describing the attributes and the respective values, and a second data form to permit the subjects to consent to the values of the attributes;
combine the first data form and the second data form into an informed consent form (ICF) for each of the subject;
obtain consent of each of the subjects to the respective ICF;
generate a manifest for each of the subjects, wherein each manifest includes the attributes and the values of the study to which the respective subject has consented, wherein each manifest further includes a version number of the attributes and the values, and wherein the version number changes when the values of the attributes change;
repeat the combining, the obtaining, and the generating when an attribute and/or a value of the first data form is modified to provide a re-generated manifest for each of the subjects who consents to the modified attribute and/or value; and
generate a report based on the re-generated manifests, wherein the report includes a listing of the subjects, values consented to, and a consent status for each subject based on the version number of uniqueness of the attributes and the values.

### Claim 13 (depends on 12)

The non-transitory computer readable medium of claim 12, wherein the study comprises clinical research and the events comprise taking and using of biological samples and specimens.

### Claim 14 (depends on 12)

The non-transitory computer readable medium of claim 12, further comprising instructions to cause the processor to identify, from the ICF, the respective subjects who consented to the events.

### Claim 15 (depends on 12)

The non-transitory computer readable medium of claim 12, further comprising instructions to cause the processor to:
re-author the first data form to modify the attributes and/or the respective values; and
combine the re-authored first data form and the second data form into an additional ICF for each of the subjects;
obtain consent of one or more of the subjects to the respective additional ICF; and
re-generate the manifest for each of the subjects who consents to the additional ICF, wherein each re-generated manifest includes the attributes and the values of the study to which the subject has consented and the version number of the attributes and the values.

### Claim 16 (depends on 15)

The non-transitory computer readable medium of claim 15, further comprising instructions to cause the processor to assign version numbers to the ICFs and the additional ICFs.

### Claim 17 (depends on 16)

The non-transitory computer readable medium of claim 16, further comprising instructions to cause the processor to de-identify patient identifying information from the manifests.

### Claim 18 (depends on 14)

The non-transitory computer readable medium of claim 14, further comprising instructions to cause the processor to digitally store the ICFs and the additional ICFs in databases accessible to computer devices via a network.

### Claim 19 (depends on 18)

The non-transitory computer readable medium of claim 18, wherein the descriptions of the events are stored as metadata and selections are stored as attributes, and wherein the attributes comprise values selected from one of static and dynamic.

### Claim 20 (depends on 1)

The method of claim 1, further including:
storing the values as metadata of the first data form; and
incorporating the metadata of the first data form and metadata of the second data form in the manifest with the respective version number.

### Claim 21 (depends on 12)

The non-transitory computer readable medium of claim 12, further comprising instructions to cause the processor to:
store the values as metadata of the first data form; and
incorporate the metadata of the first data form and metadata of the second data form in the manifest with the respective version number.

### Claim 22

A machine-implemented method of managing consent given by subjects to events in a study, wherein the events are described by attributes including values, and wherein the values are changeable, the method comprising:
authoring a first data form describing the attributes and the respective values, and a second data form to permit the subjects to consent to the values of the attributes;
combining the first data form and second data form into an informed consent form (ICF) for each of the subjects;
obtaining consent of each of the subjects to the respective ICF;
generating a manifest for each of the subjects, wherein each manifest indicates the attributes and the values of the study to which the respective subject has consented and a version number of the attributes and the values, and wherein the version number changes when the values of the attributes change;
re-authoring the first data form to modify the attributes and/or the respective values;
combining the re-authored first data form and the second data form into an additional ICF for each of the subjects;
obtaining indications of re-consent from one or more of the subjects to the modified attributes and/or the respective values with the respective additional ICF;
re-generating the manifest for each subject, wherein each re-generated manifest indicates the attributes and the values of the study to which the respective subject has re-consented and the version number of the attributes and the values; and
generating a report listing the plurality of subjects based on the manifests and the re-generated manifests, wherein the report includes a listing of the subjects, values consented to and/or re-consented to, and a consent status for each subject based on the version number of the attributes and the values.